An unprecedented phase 3 clinical trial, co-led by researchers from Winship Cancer Institute of Emory University and Children’s Healthcare of Atlanta, has revealed a new standard of care for advanced stage classic Hodgkin lymphoma. The study, published today in The New England Journal of Medicine, demonstrates that patients treated with nivolumab-AVD have significantly improved outcomes, paving the way for better treatment options for adolescents and young adults.
“This trial marks a significant advancement in the treatment of Hodgkin lymphoma, particularly for younger patients,” says Sharon Castellino, MD, MSc, member of the Cancer Prevention and Control Research Program at Winship and pediatric study chair for the trial. “The high rate of progression-free survival with nivolumab-AVD represents a paradigm shift, reducing the need for radiation therapy and its associated late effects, especially in growing children and adolescents,” adds Castellino, who is also the director of the Leukemia and Lymphoma Program at Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, professor of pediatrics at Emory University School of Medicine and scientific chair of the Hodgkin Lymphoma Committee for Children’s Oncology Group.
“Nivolumab-AVD represents a new standard of care for the treatment of patients with advanced stage Hodgkin lymphoma,” says Kristie A. Blum, MD, co-director of Winship’s Lymphoma Program, member of Winship’s Discovery and Developmental Therapeutics Research Program and professor of hematology and medical oncology at Emory University School of Medicine. “This regimen leads to 92% progression-free survival — nearly 10% better than our prior therapies — and is better tolerated by all patients.”
Data from the trial show that patients who received nivolumab (brand name Opdivo) experienced fewer side effects and had a 50% lower risk that the disease would progress after treatment, compared with patients who received the standard treatment, brentuximab vedotin (brand name Adcetris). Patients in both groups also received AVD, a conventional chemotherapy. Nivolumab is a type of immunotherapy called an immune checkpoint inhibitor, which works by releasing the immune system’s “brakes” so it can destroy classic Hodgkin lymphoma cells. Brentuximab vedotin is an antibody drug conjugate, which combines an antibody and a chemotherapy drug that work together to zero in on cancer cells and selectively destroy them.
The largest classic Hodgkin lymphoma clinical trial ever conducted in the National Clinical Trials Network (NCTN), the study enrolled 970 patients — including 237 between ages 12-17 — across 736 centers in the U.S. and Canada. Castellino, who played a pivotal role in the trial's pediatric involvement, worked alongside Kara Kelly, MD, the Waldemar J. Kaminski Endowed Chair of Pediatrics at Roswell Park Comprehensive Cancer Center. Thanks to their efforts, younger patients were able to participate in the trial.
“We anticipate that by working with the adult groups in this practice-changing clinical trial, we have paved the way for pediatric patients with advanced stage Hodgkin lymphoma to gain earlier access to checkpoint inhibitors,” says Kelly. “If we had had to wait to perform a trial for pediatric patients after the adult trial was complete, it could have taken six years or more.”
Kelly, who is also chair of the Roswell Park Oishei Children’s Cancer and Blood Disorders Program, notes the significance of this trial in treating one of the most common cancers in people ages 12-39.
Sponsored by the SWOG Cancer Research Network and funded by the National Cancer Institute, National Institutes of Health and other supporters, this study marks a major step forward in treating Hodgkin lymphoma.